Natural Health Products (NHPs)

Sale of Natural Health Products

The approval of Natural Health Products for sale follows a review by Health Canada for the product’s safety, efficacy and quality. Authorized products will be issued a product licence along with an eight-digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM), which must appear on the label. These numbers serve as a means for the public and health care professionals to know that the product is authorized to be sold on the Canadian market.

What are Natural Health Products?

Under the Natural Health Products Regulations, Natural Health Products (NHPs) are defined as:

-Vitamins and minerals
-Herbal remedies
-Homeopathic medicines
-Traditional medicines such as traditional Chinese medicines
-Probiotics
-Other products like amino acids and essential fatty acids

Labelling of Natural Health Products

All NHPs must meet specific labelling requirements, to ensure safe and informed choices. Information required on NHP labels includes:

-Product name
-Product licence number
-Quantity of product in the bottle
-Complete list of medicinal and non-medicinal ingredients
-Recommended use (including purpose or health claim, route of administration and dose)
-Any cautionary statements, warnings, contra-indications and possible adverse reactions associated with the product
-Any special storage conditions

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Canadian Disclosure Guiding Principles

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Patient-centered healthcare:
An environment of patient-centered healthcare fosters open, honest and ongoing communication between healthcare providers and patients. Healthcare services should be respectful, supportive and take into consideration the patient’s expectations and needs at all times.

Patient autonomy:
Patients have the right to know what has happened to them in order to facilitate their active involvement and decision-making in their ongoing healthcare.

Healthcare that is safe:
Patients should have access to safe healthcare services of the highest possible quality.
Lessons learned from patient safety incidents should be used to improve the practices, processes and systems of healthcare delivery.

Leadership support:
Leaders and decision makers in the healthcare environment must be visible champions of disclosure as part of patient-centered healthcare.

Disclosure is the right thing to do:
“Individuals involved at all levels of decision-making around disclosure must ask themselves what they would expect in a similar situation.”

Honesty and transparency:
When a harmful incident occurs, the patient should be told what happened.
Disclosure acknowledges and informs the patient, which is critical in maintaining the patient’s trust and confidence in the healthcare system.

From Canadian Patient Safety Institute

Exam Strategies for EE Candidates

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-Relax
-Manage your time wisely
-Read questions carefully
-Attempt the questions that are easiest for you first. Come back and do the harder ones later.
-Circle or underline important terms. Some important terms called modifiers and qualifiers are: only, always, sometimes, rarely, never, none, usually, sometimes, frequently and often
-Try to think of the answer before looking at the options

When you don’t know the answer
-Never leave a question blank
-Eliminate choices you know are incorrect at first glance to narrow the options
-If two of the alternatives are similar, give them your consideration!

Good Luck!!

Disclaimer: These exam strategies are general guidelines and do not in anyway guarantee succeeding any exam.

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Accutane

Accutane contains the active ingredient isotretinoin, a derivate of vitamin A. Accutane is used to treat severe acne resistant to other treatments including antibiotics. Accutane can cause serious side effects including birth defects and mental disorders. All patients must sign the informed consent form prior to initiating therapy. Accutane may interact with low-dose contraceptives, antibiotics, corticosteroids, phenytoin and St. John’s Wort.

Accutane should not be used:

During pregnancy
While breast feeding
During tetracyclines therapy
With vitamin A supplements
If the patient has liver or kidney disease
If the patient has high blood lipids
If the patient is sensitive to retinoids, hydrogenated soybean or parabens

Important warnings/counselling tips for female patients

You must avoid becoming pregnant while on Accutane and at least one month after the termination of therapy

If you become pregnant during Accutane therapy, stop taking the drug and contact your doctor immediately

You must use effective birth control:
- For at least one month before starting Accutane
- While you are on Accutane
- For at least one month after you stop taking Accutane

You must have two negative pregnancy tests, one of them must be done in a lab, before you start taking Accutane

You must have a monthly pregnancy test while on Accutane and one month after you stop taking the medication

Important precautions during Accutane therapy

Do not give blood
Do not have skin smoothing procedures such as waxing and dermabrasion and at least 6 months after termination of therapy
Avoid tanning
Protect skin from excessive exposure to sunlight; use sunscreen.
Do not share Accutane with other people
Do not take vitamin A
Do not take antibiotics unless recommended by a healthcare professional

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List of common drug abbreviations leading to medication error

Drug name Meaning Misinterpretation
AZT Zidovudine Azathioprine
CPZ Prochlorperazine Chlorpromazine
HCT Hydrocortisone Hydrochlorothiazide
HCTZ Hydrochlorothiazide Hydrocortisone
MTX Methotrexate Mitoxantrone

Overview of Clinical Trials Phases

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Phase I: The experimental drug is tested in a small group of healthy individuals (20-80) to evaluate its safety, determine a safe dosage range, and identify side effects.

Phase II: The experimental drug is given to a group of patients with the disease being tested (100-300) to determine the drug effectiveness, dosage, and to further evaluate its safety by monitoring side effects.

Phase III: The experimental drug is given to a larger group of patients (1,000-3,000) to confirm its effectiveness, dosage, monitor side effects, and collect all relevant information to optimize therapeutic use.

Phase IV: Also called post-marketing study. The primary goal of phase IV trial is the long term assessment of the new drug safety and effectiveness.

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Faxing a prescription

"Facsimile transmission" means transmission of the exact visual image of a document by way of electronic equipment.
Prescription drug orders may be transmitted by facsimile by a prescriber to a pharmacy, provided that the following requirements are met:
1. The prescription must be sent only to pharmacy of the patient's choice with no intervening person having access to the prescription drug order.
2. The prescription must be sent directly from the prescriber's office, directly from a health institution for a patient of that institution, or from another location, provided that the pharmacist is confident of the prescription's legitimacy.
3. The equipment for the receipt of the facsimile prescription must be located within a secure area to protect the confidentiality of the prescription information.
4. The prescription must include the:
a) Date of issue
b) Patient's name and address
c) Name of the drug or ingredient(s) and strength where applicable
d) Quantity of the drug which may be dispensed
e) Dosage instructions for use by the patient which shall include a specific frequency or interval or maximum daily dose
f) Refill authorization where applicable, which shall include the number of refills and interval between refills
g) Prescriber's Name, address, telephone number, fax number and signature or unique identifier (as approved by the Pharmacy Regulatory Authority)
h) Time and date of transmission
i) Name and fax number of the pharmacy intended to receive the transmission
j) Signed certification that:
i. the prescription represents the original of the prescription drug order,
ii. the addressee is the only intended recipient and there are no others, and
iii. the original prescription will be invalidated or retained so that it cannot be re-issued.
5. The pharmacist is responsible for verifying the origin of the transmission and the authenticity of the prescription.
6. The prescription drug order must be maintained on permanent quality paper by the pharmacy.
7. Facsimile transmission can be accepted from a practitioner registered to practice in any Canadian province.
8. Pharmacist-to-pharmacist communication of prescription transfers (for other than narcotics and controlled drugs) may be completed by facsimile transmission. The transferring pharmacist must include his or her name and the address of the pharmacy with the other required documentation as required by federal and provincial legislation. The name of the pharmacist requesting the transfer must also be known and recorded on the document to be faxed. The receiving pharmacist must ensure the authenticity of the transmission.
From NAPRA

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10 Generic Drugs Facts

1.Health Canada reviews and approves all drugs (brand-name and generic) before they can be sold in Canada.

2.Health Canada mandates that a generic drug is designed to work the same way in the body as the original brand-name drug.

3.Health Canada requires that both brand-name and generic drug companies follow the same rules for the manufacturing process and for ensuring the quality of their ingredients.

4.Health Canada mandates that generic drugs have the same active ingredient and that they work the same way in the body as the brand-name drug.

5.Generic drugs must also have the same amount of active ingredient in the prescription.

6.Health Canada even regulates the non-medicinal ingredients, such as fillers and preservatives, for both brand-name and generic drugs and they are subject to the same approval process.

7.When a generic drug is approved by Health Canada that means the medicine is as safe and as effective as the original brand-name drug and they will work the same way.

8.The only difference between a generic and a brand-name drug is the price. Generic drugs are used to fill more than 63% of all prescriptions in Canada, but they account for only 24% of the $22.1-billion dollars Canadians spend annually on prescription drugs.

9.About two-thirds of all prescriptions in Canada are filled with generic drugs.

10.Everyday in Canada, approximately one-million prescriptions are filled using generic drugs.

From The Canadian Generic Pharmaceutical Association (CGPA)

Overview of NAPRA’s National Drug Schedules (NDS)

Schedule I drugs: A prescription is required. Schedule I drugs are provided to patients by the pharmacist following diagnosis and intervention of a healthcare practitioner. The sale of schedule I drugs is controlled in a regulated environment according to provincial pharmacy legislation.

Schedule II drugs: A prescription is not required. However, schedule II drugs are available only from the pharmacist and must be stored within an area of the pharmacy where there is no public access and no opportunity for self-selection. Schedule II drugs require the professional intervention of the pharmacist at the point of sale and possibly referral to a healthcare practitioner.

Schedule III drugs: A prescription is not required. However, schedule III may present risks to certain populations in self-selection. Schedule III drugs are sold from the self-selection area of the pharmacy which is operated under the direct supervision of the pharmacist, subject to any local professional discretionary requirements which may increase the degree of control. The pharmacist is available, accessible and approachable to provide assistance.

Unscheduled drugs: Unscheduled drugs can be sold without professional supervision. Adequate information is available for the patient to make a safe and effective choice. The labeling of unscheduled drugs is deemed sufficient to ensure the appropriate use of the drug.

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Top 5 Tips for EE Review

Tip#1: Start early! The curriculum is extensive.

Tip#2: First, review the core subject areas ideally in the following order:

1. Biomedical Sciences
2 or 3. Pharmaceutical Sciences
2 or 3. Pharmacy Practice
4. Pharmacy Administration

Tip#3: Take advantage of the POWER of note taking. When you write down something you have a BETTER chance of remembering it! Get a dedicated notebook and write down key learning objectives. Here is a great guide on note taking:

Note Taking Guide

Tip#4. Study as many practice questions as you can! Practice, practice and practice!

Tip#5. Review your written notes. Your notes represent a concise summary of the core subject areas.

Disclaimer: These exam review tips are general guidelines and do not in anyway guarantee succeeding any exam.